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NCT02064387 · OUTCOME

Number of Participants With Change From Baseline in Clinical Chemistry Data With Respect to Normal Range-Part 2 (NHL)

Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916 · Source last updated 2020-08-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline and Up to 7.2 months (maximum duration of follow-up from first dose to last contact or death)

What was measured

Blood samples were collected for the analysis of following clinical chemistry parameters: D.Bil., chloride, CO2, LDH, and T.Pro. Baseline was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits.A laboratory value that is outside the reference range was considered either high abnormal (value above the upper limit of the reference range) or low abnormal (value below the lower limit of the reference range). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or NC' category. Participants were counted twice if the participant 'Decreased to Low' and 'Increased to High' during post-Baseline. Data for worst-case post Baseline is presented.

Analysis population: Part 2 NHL Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Groups in this outcome

Part 2: GSK2857916 3.40 mg/kg (NHL)

Participants with non-hodgkin's lymphoma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 36 cycles (1 cycle=21 days)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)5

Reported measurements

D.Bil.,decrease to low,n=2

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)0Not reportedNot reportedNot reportedNot reported
D.Bil., to normal or no change,n=2

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)2Not reportedNot reportedNot reportedNot reported
D.Bil.,increase to high,n=2

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)0Not reportedNot reportedNot reportedNot reported
Chloride,decrease to low,n=5

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)1Not reportedNot reportedNot reportedNot reported
Chloride, to normal or no change,n=5

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)2Not reportedNot reportedNot reportedNot reported
Chloride,increase to high,n=5

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)2Not reportedNot reportedNot reportedNot reported
CO2,decrease to low,n=5

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)2Not reportedNot reportedNot reportedNot reported
CO2, to normal or no change,n=5

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)3Not reportedNot reportedNot reportedNot reported
CO2,increase to high,n=5

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)0Not reportedNot reportedNot reportedNot reported
LDH,decrease to low,n=5

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)0Not reportedNot reportedNot reportedNot reported
LDH, to normal or no change,n=5

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)4Not reportedNot reportedNot reportedNot reported
LDH,increase to high,n=5

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)1Not reportedNot reportedNot reportedNot reported
T.Pro,decrease to low,n=5

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)1Not reportedNot reportedNot reportedNot reported
T.Pro, to normal or no change,n=5

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)4Not reportedNot reportedNot reportedNot reported
T.Pro,increase to high,n=5

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    D.Bil.,decrease to low,n=2
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    D.Bil., to normal or no change,n=2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    D.Bil.,increase to high,n=2
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    Chloride,decrease to low,n=5
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    Chloride, to normal or no change,n=5
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    Chloride,increase to high,n=5
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    CO2,decrease to low,n=5
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    CO2, to normal or no change,n=5
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    CO2,increase to high,n=5
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    LDH,decrease to low,n=5
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    LDH, to normal or no change,n=5
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    LDH,increase to high,n=5
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
Blood samples were collected for the analysis of following clinical chemistry parameters: D.Bil., chloride, CO2, LDH, and T.Pro. Baseline was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits.A laboratory value that is outside the reference range was considered either high abnormal (value above the upper limit of the reference range) or low abnormal (value below the lower limit of the reference range). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or NC' category. Participants were counted twice if the participant 'Decreased to Low' and 'Increased to High' during post-Baseline. Data for worst-case post Baseline is presented.
groups
  1. description
    Participants with non-hodgkin's lymphoma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 36 cycles (1 cycle=21 days)
    id
    OG000
    title
    Part 2: GSK2857916 3.40 mg/kg (NHL)
param Type
COUNT_OF_PARTICIPANTS
population Description
Part 2 NHL Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
reporting Status
POSTED
time Frame
Baseline and Up to 7.2 months (maximum duration of follow-up from first dose to last contact or death)
title
Number of Participants With Change From Baseline in Clinical Chemistry Data With Respect to Normal Range-Part 2 (NHL)
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice